Status:
UNKNOWN
Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Conditions:
Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these ye...
Eligibility Criteria
Inclusion
- Histological detection confirmed CD19/CD22 postive lymphoma;
- Recieved more than 2 lines of chemotherapy;
- Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
- Life expectation for more than 3 months;
- ECOG ≥ 2;
- Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT \< 2 × upper limitation of normal; SpO2 \> 92%;
- CBC results: Hb ≥ 80g/L, ANC \> 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
- Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
- With measurable disease;
- Written informed consent could be acquired;
Exclusion
- Immunosuppressive agents or steroids in recent 1 week before recruitment;
- Uncontrolled infection;
- HIV positive ;
- Active HBV or HCV infection;
- Women in pregnancy and lactation;
- Refuse to conception control during treatment and 1 year after CAR-T infusion;
- Uncured malignancies other than non-Hodgkin lymphoma;
- Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
- Inheritated immune deficiancy;
- Severe heart disease.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03468153
Start Date
January 1 2018
End Date
January 1 2020
Last Update
March 20 2018
Active Locations (1)
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1
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025